Modulation of Abeta Levels by GSK933776 in Alzheimer's Disease Patient

Alzheimer's Disease Clinical Trial

Official title:

Modulation of Beta-amyloid Levels in CSF and Plasma by GSK933776 in Patients With Mild Alzheimer's Disease or Mild Cognitive Impairment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01424436
• Other study ID #: 113043
• Status: Completed
• Phase: Phase 1
• First received: August 4, 2011
• Last updated: June 13, 2017
• Start date: May 19, 2010
• Est. completion date: December 8, 2011

Study information

• Verified date: June 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Modulation of beta-amyloid levels in CSF and plasma by GSK933776 in patients with mild Alzheimer's disease or mild cognitive impairment

Description:

This is a phase I, an open label, single dose and parallel group study to assess short term pharmacodynamics and safety of GSK933776. The effect on the beta amyloid levels will be assessed in early (MCI) and mild Alzheimer's disease (AD) patients after a single dose of GSK933776 by i.v. administration.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: December 8, 2011
• Est. primary completion date: December 8, 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 85 Years

Eligibility

Inclusion Criteria:

• Probable mild Alzheimer's disease (MMSE 20-26) or mild cognitive impairment

• Increase in total tau or p-tau in CSF

• Decrease in amyloid beta in CSF

• Stable dose of cholinesterase inhibitors, memantine or selegine or no treatment

• Body weight less than 120 kg

• Willingness to comply with contraceptive methods if self or partner is of child-bearing potential

Exclusion Criteria:

• Any other cause of dementia

• Other significant neurologic or psychiatric illness

• Hachinski Ischemia Score >4

• More than 3 microbleeds on MRI

• Type 2 diabetes not controlled by diet

• Risk of cerebrovascular disease, cerebral haemorrhage or stroke

• History of systemic autoimmune disease

• Use of platelet anti-aggregates or anti-coagulants (Aspirin up to 325 mg/day is allowable)

• Use of chronic corticosteroids

• Uncontrolled hypertension in spite of antihypertensive medications

• Renal or hepatic insufficiency or clinically significant anaemia

• In nursing home care

• Contraindications to lumbar puncture or MRI

• Prior participation in therapeutic studies only after adequate wash-out period

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Biological:
• GSK933776
1mg/kg dose group
• GSK933776
3mg/kg dose group
• GSK933776
6mg/kg dose group

Locations

Country	Name	City	State
Germany	GSK Investigational Site	Aachen	Nordrhein-Westfalen
Germany	GSK Investigational Site	Mannheim	Baden-Wuerttemberg
Germany	GSK Investigational Site	Muenchen	Bayern
Germany	GSK Investigational Site	Tuebingen	Baden-Wuerttemberg
Germany	GSK Investigational Site	Ulm	Baden-Wuerttemberg
Sweden	GSK Investigational Site	Malmö
Sweden	GSK Investigational Site	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

Germany,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The temporal changes of amyloid beta levels in CSF after GSK933776 single dose administration in the patients with Alzheimer's disease and Mild Cognitive impairment	To compare the changes of amyloid beta levels between the baseline (9 hours) and after single dose of GSK933776 iv administration of 13 hours	22 hours
Secondary	The temporal changes of total and free amyloid beta levels in plasma after GSK933776 single dose administration in the patients with Alzheimer's disease and Mild Cognitive impairment		Two months
Secondary	The temporal changes of Tau and phosphor Tau - 181 levels in CSF after GSK933776 single dose administration in the patients with Alzheimer's disease and Mild Cognitive impairment		22 hours
Secondary	Estimated pharmacokinetic parameters of AUC, Cmax and Tmax in CSF and plasma at multiple time points with various intervals.		three months
Secondary	To assess the safety and tolerability after single dose of GSK933776 administration.	The safety and tolerability measures are performed at screening, dosing day and follow up. The assessments included: • Adverse event reporting and safety laboratory data. • CNS Safety: MRI and MMSE. • CVS safety: ECG and vital signs. •Anti-GSK933776 antibodies.	three months

External Links

•   Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
•   Results for study 113043 can be found on the GSK Clinical Study Register.